About 10,000 children in the United States have been living with HIV infection since birth. Little is known about the long-term effects of HIV infection and its treatment on the growth and development of these children.

Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships.

Objectives:

To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young.

To develop ways to improve the quality of life for these individuals.

Eligibility:

-HIV-infected patients who were followed by the pediatric HIV program in NCI as of December 2004, or an HIV-infected sibling of a participant.

Design:

Periodic evaluation of pubertal development; bone mineralization; body composition and fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following:

Findings may be shared with the multicenter Pediatric HIV/AIDS Cohort Study and lead to more intensive, focused substudies.

Eligibility

Ages Eligible for Study:

6 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

INCLUSION CRITERIA:

Known HIV disease and followed in the NCI pediatric HIV program (on an NCI protocol) as of December 2004, or an HIV-infected sibling of a participant.

Age greater than 6 years.

For children greater than 7 years, ability to give assent if developmentally appropriate.

Receives care from a health care provider not affiliated with the protocol.

INCLUSION CRITERIA FOR CARDIAC IMAGING SUB-STUDY:

HIV positive participants

Known HIV disease, documented or believed to have been acquired during the first decade of life

Age greater than 7 years old

HIV negative participants

HIV negative, documented by a negative ELISA

Age greater than or equal to 18 years old and less than or equal to 30 years old

EXCLUSION CRITERIA:

Inability or unwillingness to provide informed consent for subjects greater than or equal to 18 years, and inability or unwillingness of one parent/legal guardian to provide consent for subjects less than 18 years.

Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate this study.

EXCLUSION CRITERIA FOR CARDIAC IMAGING SUB-STUDY:

Subjects with contraindication to MRI scanning. These include but are not limited to the presence of any implanted device that is incompatible with MRI.

Subjects who cannot tolerate an MRI scan or who require sedation for MRI.

Pregnant or lactating women.

History of severe allergic reaction to gadolinium contrast agents.

Estimated glomerular filtration rate less than 60 cc/min/1.73m(2).

Inability or unwillingness to provide informed consent for subjects greater than 18 years, and inability or unwillingness of one parent/legal guardian to provide permission for subjects less than 18 years.

Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgement of the Principanl Investigator (or designee) would compromise the patient s ability to tolerate this study

Some subjects may be excluded from cardiac CT but still eligible to enroll in the rest of the study. Exclusion criteria for the cardiac CT component include:

Age less than 18 years

Use of metformin-containing products less than 24 hours prior to contrast administration

History of Multiple Myeloma

Some subjects may be excluded from receiving contrast but will have a non-contrast cardiac CT. Exclusion from receiving contrast include:

Cratinine value greater than 1.4 mg/dL

History of significant allergic reaction to CT contrast agents

Some subjects may receive the cardiac CT but will be excluded from receiving beta-blocker. Exclusion criteria for receiving beta-blocker include:

Asthma

Active bronchospasm

Moderate or severe COPD

2nd or 3rd degree AV block

Decompensated cardiac failure

Allergy to beta blockers

Systolic blood pressure less than 100 mm HG

Resting heart rate at the time of scan less than 60 if regular and less than 65 if irregular

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924365